DARWIN EU® - Sex differences in treatment patterns for venous thromboembolic events in European countries

06/08/2026
06/08/2026
EU PAS number:
EUPAS1000001079
Study
Ongoing
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Study summary
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Study identification

EU PAS number

EUPAS1000001079

Study ID

1000001079

Official title and acronym

DARWIN EU® - Sex differences in treatment patterns for venous thromboembolic events in European countries

DARWIN EU® study

Yes

Study countries

Denmark
Finland
Netherlands
Spain
United Kingdom

Study description

While potential sex differences in cardiovascular treatment have been widely discussed, existing evidence remains fragmented. In particular, there is a lack of consistent, large-scale Real-World Evidence to objectively assess whether meaningful treatment gaps exist across European healthcare systems in routine clinical practice. For venous thromboembolic events (VTE), sex differences in anticoagulation treatment may arise from variations in bleeding risk, pharmacokinetics, and hormonal influences such as oral contraceptives and hormone replacement therapy (HRT). Important evidence gaps remain regarding anticoagulant treatment strategies in females, particularly the concomitant use of anticoagulants with hormonal contraception and HRT. Consequently, the current clinical guideline recommended has adapted anticoagulant treatments for individuals with renal impairment, cancer, or extreme under/overweight. Evaluating differences in treatment choice and switching patterns between males and females may provide valuable insights into routine clinical practice and potential gaps in care.
As part of the broader European Medicines Agency (EMA) Women's Health Initiative, this study aims to evaluate potential sex differences in anticoagulant treatment for VTE. By examining sex-specific patterns in treatment initiation and subsequent treatment pathways, the study seeks to identify potential gaps in care that may inform clinical practice, regulatory decision-making, and public health strategies aimed at promoting equitable, evidence-based treatment.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ivan Lam

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable